Job Vacancies at Syneos Health Clinical Solutions

Job responsibilities

Project Leadership and Delivery:

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
• Lead project team to ensure quality, timelines and budget management.
• Accountable for the financial performance of each project. 
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. 
• Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
• Accountable for all project deliverables for each project assigned.

Documentation and Reporting:

• Responsible for quality and completeness of TMF for assigned projects.
• Accountable for maintenance of study information on a variety of databases and systems.
• Responsible for study management components of inspection readiness for all aspects of the study conduct. 
• Oversight for development and implementation of project plans.
• Plan, coordinate and present at internal and external meetings.
• Prepare project management reports for clients and management.
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals. 

Business Development:

• Develops strong relationships with current clients to generate new and/or add-on business for the future.  
• May participate in bid defense meetings where presented as potential project manager.

Management:

• May be required to line manage other project management team members and clinical monitoring staff.

Qualifications

What we’re looking for

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.  
• Clinical research organization (CRO) and relevant therapeutic experience preferred.  Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Direct therapeutic area expertise.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Ability to travel as necessary (approximately 25%).

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Job responsibilities

• Prepares or assists in preparing statistical analysis plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with other senior biostatistics personnel as needed and with sponsor, if required.    
• May act as Lead Biostatistician, and be responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• As a supporting Biostatistician, provide assistance to senior staff members in the performance of statistical responsibilities (e.g., randomization, sample size estimation).Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Manages scheduling and time constraints across multiple projects, set goals based on priorities from Lead Biostatistician and management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to the Lead Biostatistician or Biostatistics management any difficulties with meeting these timelines.  
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management.
• Provides statistical programming support as needed.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
• May support business development activities by attending sponsor bid defense meetings.
• Performs other work-related duties as assigned.  
• Minimal travel may be required.

Qualifications

What we’re looking for

• Previous lead experience within Late Phase Clinical Trials is required.
• Graduate degree in biostatistics or related discipline.
• Moderate experience in clinical trials or an equivalent combination of education and experience.
• Programming experience, preferably in a clinical trials environment.
• Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.

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Job responsibilities

• May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.  
• Produces site-specific contracts from country clinical trial agreement (CTA) template.  Reviews and owns site-specific contracts from country template.  Submits proposed CTA and investigator budget for site review.
• Negotiates budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
• Works closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.  
• Works closely with SSU lead, Clinical Operations and Finance to validate the load of departmental budgets and corresponding backlog.
• Identifies possible contract or process operational risk and proactively works within the team to provide solutions.  Establishes strong working relationships with SSU lead, customer and internal project teams.  Escalates deviations to department leadership and/or Site Contract Service Center and/or Legal Department.
• Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Maintains and actively supports review and development of contract templates, budget templates and site specific files and databases.
• Serves as key communication liaison between site contracts staff and internal and external customers.  Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues.  Prepares correspondence as necessary. 
• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs), and ensures quality of team work products.  Maintains and updates training material for site contract team.
• Actively participates in higher level discussions about overall company goals, departmental objectives, and specific project aims.
• Facilitates the execution of contracts by company signatories.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

Qualifications

What we’re looking for

• Must be fluent in English and Turkish
• Essential to have working experience of Turkish Clinical Site Contracts
• BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.  Advanced degree preferred 
• Moderate contracts management experience that includes experience in a contract research organization or pharmaceutical industry  
• Management experience preferred 
• Strong knowledge of the clinical development process and legal and contracting parameters
• Strong computer skills in Microsoft Office Suite  
• Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
• Good understanding clinical protocols and associated study specifications 
• Excellent understanding of clinical trial start-up processes
• Project management experience in a fast-paced environment
• Good vendor management skills Strong organizational skills with proven ability to handle multiple projects
• Excellent communication, presentation and interpersonal skills 
• Quality-driven in all managed activities 
• Strong negotiating skills
• Strong problem-solving skills 
• Ability to mentor and motivate more junior staff 
• Demonstrate an ability to provide quality feedback and guidance to peers 
• Contribute to a training and Quality assurance plan within SSU and update SOPs/WI